Stryker recalls certain Femoral Nails (R150:12x380mm) due to potential reduced strength causing premature breakage. Affected products have specific product numbers and lot codes.
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Stryker is recalling specific femoral nails that may have weaker strength, increasing the risk of breaking during use. This could lead to complications in medical procedures.
The nails may have been manufactured outside specifications, leading to reduced strength. This could cause the nails to break during surgical procedures, potentially causing complications.
Medical professionals using the recalled femoral nails for surgeries are most at risk. Patients receiving these implants may also face complications if the nails break prematurely.
Check for the product number 18281238S, lot code K08327F, or GTIN 04546540200693 on the packaging or label. The nails are labeled as Femoral Nail, A/R, R1500 T2 Femur 12x380 mm.
Verify the product number (18281238S), lot code (K08327F), or GTIN (04546540200693) on the packaging or label.
The manufacturer discovered that some products may have been made outside specifications, which could lead to reduced strength and premature breakage.
Check the product number, lot code, or GTIN on the packaging or label to confirm if it's affected. If it matches, contact Stryker for further instructions.
The recall is for potential premature breakage during use, which could lead to complications but does not indicate a risk of serious injury in normal use.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2401-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2401-2018 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.